Comment period on “Sunshine” regulations closes

Section 6002 of the Patient Protection and Affordable Care Act requires disclosure of payments by the drug and device industry to physicians and teaching hospitals.  On December 14, 2011, the Centers for Medicare and Medicaid Services proposed regulations that would implement these “sunshine” provisions.  See this Pharmalot post for background.  I also recommend this commentary by Robert Steinbrook and Joseph Ross.  The comment period closed on February 17, and I submitted a comment, excerpted below.  You can access the proposed regulations and comments by going to and searching on “CMS-5060-P.”

Re:       Transparency Reports and Reporting of Physician Ownership or Investment Interests; CMS-5060-P

Dear Ms. Tavenner:

I am writing to support the adoption of the above-referenced proposed rules implementing section 6002 of the Patient Protection and Affordable Care Act of 2010 (PPACA).  As you know, this section of the PPACA requires drug, device, biological, or medical supply manufacturers to report certain payments and transfers of value to covered recipients, entities, individuals and teaching hospitals.  The reported information would be available on a public website.

I believe the rules should be adopted substantially as proposed.  In particular, I believe it is essential for the rules to require disclosure of both direct and indirect payments.  Indirect payments include those a company makes to a third party, such as a medical society, contract research organization, or medical education and communication company, but that are ultimately intended for a physician or other covered recipient.  The reporting of indirect payments is essential to meet the goals of transparency and completeness and to prevent the institution or continuation of arrangements that impede full disclosure of the financial relationships between industry and the medical profession.

In addition, I urge you to give careful consideration to the design of the proposed website.  It should be designed to make possible it easy for members of the general public to find all payments to a particular provider or entity in one search regardless multiple addresses or variations in names (e.g., with or without a middle initial).  I urge CMS to provide an opportunity for public discussion and comment on the proposed website design, such as through a public forum and/or focus groups.

Finally, I urge CMS to provide greater detail on specific enforcement mechanisms to ensure that manufacturers comply promptly and completely with the reporting requirements. 

Thank you for the opportunity to comment on this important proposed regulation.


                                                                         Marilyn Mann

Posted on February 19, 2012, in conflicts of interest and tagged , , , , , , . Bookmark the permalink. 1 Comment.

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

%d bloggers like this: